PaxilÂ®, aÂ SSRI (Selective Serotonin Reuptake Inhibitors) antidepressant, been linked to serious and possibly fatal side effects. PaxilÂ® (paroxetine hydrochloride), also known as Seroxat in Europe, is manufactured by GlaxoSmithKline. It is a prescription drug prescribed for depression, panic disorders, social behavior disorders, and obsessive-compulsive disorder.Â The product liability lawsuits allege that Glaxo executives withheld critical safety and serious side effects information from the FDA despite requirements to disclose the evidence. Glaxo has reported nearly $1 billion in annual Paxil drug sales. Medical Studies in 2005 found that PaxilÂ® is directly related to infant heart defects, although this critical birth defect information was not disclosed to consumers.Â Â
A recent British Medical Journal study found that women taking PaxilÂ® while undergoing a specific cancer treatment may have an increased risk of death. Recent lawsuits about Paxil allege the drug maker SmithKlein Beecham dba GlaxoSmithKline continued to promote Paxil while withholding evidence that it caused significant birth defects, making consumers believe that it was safe to use while pregnant.Â Approved by the FDA in 1992, Glaxo scientists raised concerns about birth defects linked to Paxil as early as 1997.Â Â If you have used PaxilÂ® or an SSRI drug while pregnant and experience side effects or problems, consult your prescribing physician immediately.
Â Studies suggest use of Paxil and other types of antidepressants during pregnancy may cause serious birth defects including:
- brain and spinal cord injury
- heart injury
- lung injury
- abnormally shaped head/skull
- abdominal wall injury
- club foot
- closure of the anus
On December 8, 2005 the U.S. Food and Drug Administration (FDA) issued a Public Health Advisory for Paxil, based on American and Swedish studies, showing that use of Paxil in the first trimester of pregnancy may increase the risk of heart defects.
The FDA issued a second advisory on July 19, 2006, based on evidence showing their use may be linked to persistent pulmonary hypertension (PPHN), a life-threatening lung condition.
If you or your child suffered side effects following the use of Paxil or other antidepressants, please contact us for a free and confidential case review.
INFORMATION, ADVISORIES & ALERTS FROM THE FDA
December 8, 2005: FDA Public Health Advisory on Paxil (Paroxetine)
The Food and Drug Administration (FDA) has determined that exposure to paroxetine in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations. At the FDA's request, the manufacturer has changed paroxetine's pregnancy category from C to D and added new data and recommendations to the Warnings section of paroxetine's prescribing information. Paroxetine is available as Paxil, Paxil CR, Pexeva, and generic paroxetine hydrochloride.
The FDA's conclusions and changes in paroxetine's prescribing information are based on preliminary analyses of two recent unpublished epidemiology studies.
- In a study using Swedish national registry data, women who received paroxetine in early pregnancy had an approximately 2-fold increased risk for having an infant with a cardiac defect compared to the entire national registry population (the risk of a cardiac defect was about 2% in paroxetine-exposed infants vs. 1% among all registry infants).
- In a separate study using a United States insurance claims database, infants of women who received paroxetine in the first trimester had a 1.5-fold increased risk for cardiac malformations and a 1.8-fold increased risk for congenital malformations overall compared to infants of women who received other antidepressants in the first trimester. The risk of a cardiac defect was about 1.5% in paroxetine-exposed infants vs. 1% among infants exposed to other antidepressants.
Most of the cardiac defects observed in these studies were atrial or ventricular septal defects, conditions in which the wall between the right and left sides of the heart is not completely developed. In general, septal defects are one of the most common type of congenital malformations. They range from those that are symptomatic and may require surgery to those that are asymptomatic and may resolve on their own. It is of note that the data in these studies was limited to first trimester exposures only, and there are not currently data to address whether this or any other risk extends to later periods of pregnancy.
The FDA is awaiting the final results of the recent studies and accruing additional data related to the use of paroxetine in pregnancy in order to better characterize the risk for congenital malformations associated with paroxetine. In the interim, FDA recommends the following:
Physicians who are caring for women receiving paroxetine should alert them to the potential risk to the fetus if they plan to become pregnant or are currently in their first trimester of pregnancy. Discontinuing paroxetine therapy should be considered for these patients. In individual cases, the benefits of continuing paroxetine may outweigh the potential risk to the fetus. If the decision is made to discontinue paroxetine and switch to another antidepressant or cease antidepressant therapy, paroxetine discontinuation should be undertaken only as directed in the prescribing information. Paroxetine should generally not be initiated in women who are in their first trimester of pregnancy or in women who plan to become pregnant in the near future.
Women who are pregnant, or planning a pregnancy, and currently taking paroxetine should consult with their physician about whether to continue taking it. Women should not stop the drug without discussing the best way to do that with their physician.
July 19, 2006: FDA Alert On Paxil and Other SSRI Antidepressants
FDA ALERT [7/2006]: Increased Risk of Neonatal Persistent Pulmonary Hypertension
A recently published case-control study has shown that infants born to mothers who took selective serotonin reuptake inhibitors (SSRIs) after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy (see SSRI drug names at the bottom of this sheet). The background risk of a woman giving birth to an infant affected by PPHN in the general population is estimated to be about 1 to 2 infants per 1000 live births. Neonatal PPHN is associated with significant morbidity and mortality. The FDA is updating the prescribing information for all SSRIs with this new information. The FDA is also accruing data from additional sources pertaining to the potential association between SSRIs and neonatal PPHN. The FDA will provide additional information when it becomes available. In the interim, the FDA recommends that physicians carefully consider and discuss with patients the potential risks and benefits of SSRI treatment throughout pregnancy, including late pregnancy.
This information reflects FDA's current analysis of data available to FDA concerning these drugs. FDA intends to update this sheet when additional information or analyses become available.
To report any unexpected adverse or serious events associated with the use of this drug, please contact the FDA MedWatch program.
Physicians should consider the benefits and risks of treating pregnant women with SSRIs, alternative treatments, or no treatment late in pregnancy.
A retrospective case-control study published on February 9, 2006, in the New England Journal of Medicine assessed the risk for persistent pulmonary hypertension of the newborn (PPHN) following exposure to SSRIs during pregnancy. 377 women whose infants were born with PPHN and 836 women whose infants were healthy were enrolled in the study in four United States metropolitan areas between 1998 and 2003. The study showed that infants born to mothers who took SSRIs after the completion of the 20th week of gestation were 6 times more likely to have PPHN than infants who were not exposed to antidepressants during pregnancy. 14 infants with PPHN and 6 healthy control infants had been exposed to an SSRI after the 20th week of gestation. There were too few cases of PPHN with each individual SSRI to compare risks for PPHN with individual SSRIs. The study did not find an association between exposure to SSRIs during the first 20 weeks of gestation and PPHN.
Exposure to non-SSRI antidepressants did not appear to be associated with an increased risk of PPHN, although the number of infants with exposure to non-SSRI antidepressants was too small to permit a reliable risk estimate or comparison with the risk observed for SSRIs.
In weighing the risks and benefits of treatment with SSRIs and other antidepressants during pregnancy for individual patients, physicians should also note the recent publication of a prospective longitudinal study of 201 pregnant women with a history of major depression in the February 1, 2006, issue of JAMA. In this study, women who discontinued antidepressant medication during pregnancy had a higher risk of relapse of major depression during pregnancy (68%) than women who maintained antidepressant medication throughout pregnancy (26%).
SSRI Drug Names
- Celexa (citalopram)
- Lexapro (escitalopram)
- Paxil (paroxetine)
- Prozac (fluoxetine)
- Symbyax (olanzepine/fluoxetine)
- Zoloft (sertraline)
JULY 2006: FDA HEALTH ADVISORY
Treatment Challenges of Depression in Pregnancy and the Possibility of Persistent Pulmonary Hypertension in Newborns
Decisions about how to treat depression in pregnant women are increasingly complex. Patients and physicians must carefully consider and discuss together the potential benefits and risks of treatment with antidepressants during pregnancy. Two new studies provide important information to be considered in making such decisions. The studies included women who had been treated with antidepressant drugs that act as selective serotonin reuptake inhibitors (SSRIs) or, in a few cases, other antidepressants. SSRI medications are the most commonly used drugs to treat depression in the U.S.
The first study illustrates the potential risk of relapsed depression after stopping antidepressant medication during pregnancy. The authors followed pregnant women who in the past had major depression. During their pregnancy, some of these women were not feeling depressed and stopped taking their antidepressant medicines. Others stayed on their antidepressant medicines while pregnant. The women who stopped their medicine were five times more likely to have a relapse of depression during their pregnancy than were the women who continued to take their antidepressant medicine while pregnant. This study, by Lee Cohen and other authors, was published February 1, 2006 in the Journal of the American Medical Association (JAMA).
A second study suggests there may be additional, though rare, risks of SSRI medications during pregnancy. This study focused on newborn babies with persistent pulmonary hypertension (PPHN), which is a serious and life-threatening lung condition that occurs soon after birth of the newborn. Babies with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream. About 1 to 2 babies per 1000 babies born in the U.S. develop PPHN shortly after birth, and often they need intensive medical care. In this study PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of the pregnancy compared to babies whose mothers did not take an antidepressant. The study was too small to compare the risk in one drug compared to another, and this risk has not so far been investigated by other researchers. The study, by Christina Chambers and others, was published on February 9, 2006 in The New England Journal of Medicine.
The finding of PPHN in babies of mothers who used a SSRI antidepressant in the second half of pregnancy adds to concerns coming from previous reports that infants of mothers taking SSRIs late in pregnancy may experience difficulties such as irritability, difficulty feeding and in very rare cases, difficulty breathing. In addition, the labeling for paroxetine (Paxil) was recently changed to add information about findings in an epidemiology study suggesting that exposure to the drug in the first trimester of pregnancy may be associated with an increased risk of cardiac birth defects (see FDA Public Health Advisory for Paxil dated December 8, 2005).
The uncommon potential risk to the newborn of PPHN has not been confirmed by additional studies. Uncertainty about these rare events and their potential impact on the newborn, along with the potential risk to the mother of recurring depression if she stops her antidepressant medicines during pregnancy, makes decisions about the treatment of depression in pregnant women especially challenging for health care professionals and patients.
Women who are pregnant or thinking about becoming pregnant should not stop any antidepressant without first consulting their physician. The decision to continue medication or not should be made only after there has been careful consideration of the potential benefits and risks of the medication for each individual pregnant patient. If the decision is made to stop treatment with SSRIs before or during pregnancy, this should be done with a healthcare professional, according to the prescribing information for the drug, and patients should be observed closely in case their depression comes back.
The FDA is seeking additional information about the possible risk of PPHN in newborn babies of mothers who took SSRI antidepressants in pregnancy. In the meantime, the FDA has asked the sponsors of all SSRIs to change prescribing information to describe the potential risk for PPHN. Prescribing information will be updated with information from additional studies when this information becomes available.
SSRIs and a Combination Drug Containing an SSRI
- Celexa (citalopram)
- Lexapro (escitalopram)
- Paxil (paroxetine)
- Prozac (fluoxetine)
- Symbyax (olanzapine/fluoxetine)
- Zoloft (sertraline)